JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

The objective of Quality by Design is a modern, approach that formalizes

product design, automates manual testing and streamlines trouble shooting. It uses a systemic approach to ensure quality by developing a thorough understanding of the compatibility of a finished product to all the components and processes involved in manufacturing that product.

Course Outcome

This subject aims at

• More efficient use of development time and costs
• Ability to meet FDA Submission Guidelines and expectations
• Reduced approval times and fewer queries

UNIT - I

Overview of QbD Introduction, history of QbD, Regulatory aspects of QbD, Pharmaceutical quality by testing, Elements of QbD, benefits of QbD and current state of QbD.

UNIT - II

Aspects of QbD to product development: Introduction, Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical process parameters, risk assessment, design space, control strategy, product lifecycle management and continual improvement.

UNIT - III

DOE, PAT and RTRT: Design of Experiment (DOE), Process Analytical Techniques (PAT), Real Time Release Testing (RTRT).

UNIT - IV

Implementation of QbD in product development (case studies): Introduction, Implementation of QbD in tablet formulation, implementation of QbD in pellet formulation.

UNIT - V

Implementation of QbD in product development (case studies): Implementation of QbD in emulsion formulation, Implementation of QbD in powder formulation and Implementation of QbD in Liposomes formulation.

REFERENCES:

• 1. Introduction to Quality by Design for Pharmaceuticals by Nilesh Desai and Manohar A. Potdar
• 2. Quality by Design (QbD): A new concept for Development of quality Pharmaceuticals by Patil.A.S. and Pethe M.Pharm I Year II Sem (Industrial Pharmacy)